Breast Cancer
Conditions
Keywords
stage IV breast cancer, recurrent breast cancer
Brief summary
RATIONALE: Vaccines made from breast cancer cells may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccines made from breast cancer cells in treating women with metastatic breast cancer.
Detailed description
OBJECTIVES: * Determine the safety and toxicity of vaccination strategies employing a CD80-transfected allogeneic breast cancer cell line (MDA-MB-231). * Assess the immunologic response of lymphocytes isolated from lymph nodes draining the vaccination site following a single dose of CD80-transfected MDA-MB-231. * Assess the development of systemic immunity following multiple injections of CD80-transfected MDA-MB-231. * Observe for tumor regression. OUTLINE: This is a dose-escalation study. Patients receive intradermal vaccinations containing CD80-transfected cells with or without sargramostim (GM-CSF) or with or without BCG. Vaccinations are administered every 2 weeks for 6 weeks and then monthly for 3 months. Patients may receive 1 of 2 different doses of GM-CSF. GM-CSF is administered with the vaccination, then every 12 hours for 7 days. Monthly vaccinations may continue as long as response is shown. Cohorts of 5 patients each are treated at each dose/combination. Each cohort completes treatment before the next cohort is accrued. Patients are followed at weeks 4 and 8, then every 2 months for 6 months, then every 3 months for 1 year, and then every 6 months until disease progression. PROJECTED ACCRUAL: Approximately 35 patients will be accrued for this study within 18 months.
Interventions
BIOLOGICALBCG vaccine
BIOLOGICALCD80 breast cancer vaccine
BIOLOGICALsargramostim
Sponsors
Providence Cancer Center, Earle A. Chiles Research Institute
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically proven metastatic breast cancer * Stage IV disease patients who have either been treated to maximal response or who have had high dose chemotherapy or a marrow ablative regimen (if they meet immunologic criteria and have not received more than 2 chemotherapy regimens for treatment of metastatic disease) * Patients with advanced stage disease who: * Received at least 1 standard chemotherapy regimen, but no more than 2, for treatment of metastatic disease * Refused chemotherapy * Refused or progressed despite hormonal therapy * Measurable or evaluable disease * Positive or negative for HLA-A2 * Must have superficial inguinal or axillary lymph nodes that are free of tumor involvement and are surgically accessible * No symptomatic or acutely life threatening tumor that is judged likely to require intervention with alternative modalities within 3 months * No brain metastases * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Female Menopausal status: * Not specified Performance status: * ECOG 0 or 1 Life expectancy: * Not specified Hematopoietic: * WBC greater than 3,000/mm\^3 Hepatic: * Not specified Renal: * BUN less than 25 mg/dL * Creatinine less than 1.8 mg/dL Cardiovascular: * No ischemic or congestive cardiac disease requiring chronic medication * No New York Heart Association class III or IV heart disease * No evidence of ischemic change or ventricular ectopy (greater than 4/min) on electrocardiogram (EKG) * No evidence of type II arterial-ventricular block * No evidence of current cardiac disease by stress test and EKG Other: * HIV negative * No active infection requiring treatment * No psychiatric illness * No history of seizure disorder * No other prior malignancy within the past 10 years except squamous cell or basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior specific or nonspecific immunotherapy, unless there is obvious progression of metastatic disease, and recovered Chemotherapy: * See Disease Characteristics * At least 4 weeks since prior chemotherapy, unless there is obvious progression of metastatic disease, and recovered Endocrine therapy: * At least 4 weeks since prior steroids, unless there is obvious progression of metastatic disease, and recovered Radiotherapy: * Concurrent radiotherapy allowed for local control of disease Surgery: * Not specified
Countries
United States
Outcome results
None listed